Patterns of Initial Opioid Prescribing to Opioid-Naive Patients.

OBJECTIVE: To determine the proportion of initial opioid prescriptions for opioid-naive patients prescribed by surgeons, dentists, and emergency physicians. We hypothesized that the percentage of such prescriptions grew as scrutiny of primary care and pain medicine opioid prescribing increased and guidelines were developed. SUMMARY OF BACKGROUND DATA: Data regarding the types of care for which opioid-naive patients are provided initial opioid prescriptions are limited. METHODS: A retrospective cross-sectional study using a nationwide insurance claims dataset to study US adults aged 18 to 64 years. Our primary outcome was a change in opioid prescription share for opioid-naive patients undergoing surgical, emergency, and dental care from 2010 to 2016; we also examined the type and amounts of opioid filled. RESULTS: From 87,941,718 analyzed lives, we identified 16,292,018 opioid prescriptions filled by opioid-naive patients. The proportion of prescriptions for patients receiving surgery, emergency, and dental care increased by 15.8% from 2010 to 2016 (P < 0.001), with the greatest increases related to surgical (18.1%) and dental (67.8%) prescribing. In 2016, surgery patients filled 22.0% of initial prescriptions, emergency medicine patients 13.0%, and dental patients 4.2%. Surgical patients' mean total oral morphine equivalents per prescription increased from 240 mg (SD 509) in 2010 to 403 mg (SD 1369) in 2016 (P < 0.001). Over the study period, surgical patients received the highest proportion of potent opioids (90.2% received hydrocodone or oxycodone). CONCLUSIONS: Initial opioid prescribing attributable to surgical and dental care is increasing relative to primary and chronic pain care. Evidence-based guideline development for surgical and dental prescribing is warranted in order to curb iatrogenic opioid morbidity and mortality.

Hospital-Based Emergency Department Visits With Pediatric Burns: Characteristics and Outcomes.

OBJECTIVE: The objective of this study was to examine the characteristics and outcomes in children presenting to emergency departments (EDs) with burn injuries. METHODS: The Nationwide Emergency Department Sample (NEDS) for the years 2008 to 2013 was used. All patients younger than 18 years who visited a hospital-based ED with a burn injury were selected. The study focused on (1) demographics (age, sex, insurance status), (2) characteristics of burns (types, causes), (3) disposition status after ED/hospitalization, (4) charges (ED and hospital), and (5) patient outcomes. Inclusion criteria were a visit to ED in the United States with a burn. Descriptive statistics were used to summarize the findings. RESULTS: During the study period, there were 746,593 ED visits due to burn injuries. Majority were insured by Medicaid (52.8%). Most frequent injuries were burns of wrists/hands (39.5%), lower limbs (24.1%), and upper limb-except wrist/hand (20.1%). The most common causes of burns were heat from electric appliances (37.1%) or hot liquids and vapors (24.8%). Following the ED visit, 89.1% were discharged routinely, and 4.3% were admitted. Mean charge per patient per ED visit was $1117. Total ED charges across the United States was $708.7 million. When admitted, mean length of stay was 5.7 days. Total hospitalization charge across the United States was $1.7 billion. CONCLUSIONS: Pediatric burn injuries require significant resources for stabilization and treatment by EDs. The present study highlights the burden and impact of pediatric burn injuries in the United States.

Orthodontics in the era of big data analytics.

The objective of this report was to provide an overview of the current landscape of big data analytics in the healthcare sector, introduce various approaches of machine learning and discuss potential implications in the field of orthodontics. With the increasing availability of data from various sources, the traditional analytical methods may not be conducive anymore for examining clinical outcomes. Machine-learning approaches, which are algorithms trained to identify patterns in large data sets, are ideally suited to facilitate data-driven decision making. The field of orthodontics is particularly ripe for embracing the big data analytics platform to improve decision making in clinical practice. The availability of omics data, state-of-the-art imaging and potential for establishing large clinical data repositories have favourably positioned the specialty of orthodontics to deliver personalized and precision orthodontic care. Specifically, we discuss about next-generation sequencing, radiomics in the context of CBCT imaging, and how centralized data repositories can enable real-time data pooling from multiple sources.

Opioid Abuse and Dependence in Those Hospitalized Due to Head and Neck Cancer.

PURPOSE: In the United States, 2.1 million people develop substance abuse disorders that are associated with prescribed opioids. The objective of the present study was to identify the factors associated with opioid abuse and dependence (OAD) in those hospitalized for head and neck cancer (HNC). Although measures are being implementing to reduce opioid prescribing, the use of these drugs in individuals with HNC can be valuable. However, little is known about OAD among this cohort of individuals. MATERIALS AND METHODS: The present study was a retrospective analysis of the Nationwide Inpatient Sample for 2012 to 2014. All patients hospitalized because of any HNC were selected. The OAD prevalence was identified. The patient demographic, hospital, and geographic factors were considered independent variables and OAD was the outcome. Multivariable logistic regression model was used to identify the factors associated with OAD. RESULTS: A total of 92,055 patients were hospitalized because of HNCs. OAD was prevalent in 0.8% of the patients. The OAD rates were greatest in patients with a malignant neoplasm of ill-defined sites within the lip, oral cavity, and pharynx (1.6%). Age 30 to 44 years (odds ratio [OR] 5.19, 95% confidence interval [CI] 2.23 to 12.06; P < .01) and age 45 to 64 years (OR 4.05, 95% CI 2.15 to 7.61; P < .01) were associated with greater odds for OAD compared with age older than 64 years. Black (OR 1.76, 95% CI 1.12 to 2.78; P = .01) and Hispanic (OR 2.20, 95% CI 1.27 to 3.79; P < .01) race/ethnicity were associated with greater odds for OAD compared with white race/ethnicity. Individuals covered by Medicaid (OR 2.08, 95% CI 1.26 to 3.43; P < .01), and those who were uninsured (OR 2.27, 95% CI 1.05 to 4.89; P = .04) were associated with greater odds for OAD compared with those covered by private insurance. An increase in the comorbid burden was associated with increased odds of OAD (OR 1.57, 95% CI 1.47 to 1.68; P < .001). CONCLUSIONS: The present study identified specific anatomic sites where malignant neoplasm was associated with greater odds of OAD. Additionally, the study found that coverage by Medicaid, black and/or Hispanic race/ethnicity, lowest income households, and a greater comorbid burden were associated with greater odds of OAD.

Facial Fractures in Patients With Firearm Injuries: Profile and Outcomes.

PURPOSE: Firearm injuries (FAIs) are a major public health issue in the United States. The objective of this study was to examine characteristics and outcomes of patients presenting to emergency departments (EDs) with facial fractures attributed to FAIs. MATERIALS AND METHODS: The Nationwide Emergency Department Sample for the years 2008 to 2013 was used. All patients who visited EDs with FAIs and facial fractures were selected. The study focused on the following variables: 1) demographic characteristics, 2) types of facial fractures, 3) disposition status after ED visit or subsequent hospitalization, 4) charges (ED and hospitalization), and 5) patient outcomes. The inclusion criteria were a visit to a hospital-based ED with facial fractures and an external cause of FAI. Descriptive statistics were used to summarize findings. Multivariate logistic regression analysis was used to examine the simultaneous effects of patient-related factors on ED death. RESULTS: During the study period, a total of 15,469 patients (mean age, 34 years) visited hospital-based EDs with facial fractures attributed to FAIs. Most were uninsured male patients. The most common etiology of FAIs was assault. The most common facial fractures were open mandibular fractures and open maxillary and/or malar bone fractures. Approximately 27% of patients had a concomitant intracranial injury. After the ED visit, 74% were admitted. The mean ED charge per patient was $6,403, and the total ED charge across the United States was $76.48 million. The mean hospitalization charge per patient was $167,203. The total hospitalization charge across the United States was $1.9 billion. Patients with intracranial injuries (odds ratio [OR], 21.21; 95% confidence interval [CI], 7.16 to 62.85; P < .01), uninsured patients (OR, 4.24; 95% CI, 1.44 to 12.51; P < .01), and patients residing in areas with high household incomes (OR, 5.60; 95% CI, 2.51 to 12.46; P < .01) were high-risk groups for ED death. CONCLUSIONS: FAIs require substantial resources for stabilization and treatment by EDs. This study highlights the burden and impact of facial fractures in patients with FAIs in the United States.

Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database.

INTRODUCTION: The objectives of this study were to examine adverse clinical events after the use of the Invisalign system and to provide an overview of the actions taken by the manufacturer to address these events. METHODS: A retrospective analysis of the Manufacturer and User Facility Device Experience database of the United States Food and Drug Administration was used. All medical device reports reported to the United States Food and Drug Administration pertaining to products of Align Technology from November 1, 2006, to November 30, 2016, were analyzed. Qualitative content analysis was conducted of event descriptions and manufacturer narrative reports. RESULTS: A total of 173 medical device reports were reported in the Manufacturer and User Facility Device Experience database: 169 (97.7%) were designated as adverse event reports, and 45 (26%) were deemed by the treating doctor to be serious or life threatening. The most medical device reports that reported a serious or life-threatening event were in 2014 (50%). The most frequently reported adverse event was difficulty breathing (56 events) followed by sore throat (35 events), swollen throat (34 events), swollen tongue (31 events), hives and itchiness (31 events), anaphylaxis (30 events), swollen lips (27 events), and feeling of throat closing/tight airway/airway obstruction/laryngospasm (24 events). CONCLUSIONS: Serious or life-threatening events could be associated with use of Invisalign systems. Health care providers should be aware of these events and know how to handle them if they arise in their practices.

Impact of Periapical Abscess on Infectious Complications in Patients Undergoing Extracorporeal Circulation Auxiliary to Open-Heart Surgical Procedures.

OBJECTIVE: Extracorporeal circulation auxiliary to open-heart surgeries (ECAOHS) may exert nonphysiological stresses on periapical abscessed tissues leading to hematogenous spread of microbes. The aim of this report was to estimate risk of postoperative infectious complications in patients with periapical abscesses and undergoing ECAOHS. METHODS: A retrospective analysis of Nationwide Inpatient Sample (years 2009 and 2010) was conducted. All patients (aged 19 to 65 years) who underwent ECAOHS were selected. International Classification of Diseases-9-Clinical Modification codes were used to identify the presence of periapical abscess and infectious complications. Multivariable logistic regression models were used to examine the associations between the presence of periapical abscess and occurrence of infectious complications. RESULTS: A total of 265,235 patients underwent an ECAOH procedure. Of these, 431 patients had a periapical abscess. Septicemia developed in 16% of those with periapical abscess (compared with 4.2% in those without periapical abscess). Those with periapical abscess had higher rates of any of the infectious complications when compared with those without periapical abscess (30.2% vs 11.6%, respectively). After adjustment for multiple confounders, those with periapical abscess were associated with higher odds for developing septicemia (odds ratio = 2.51, 95% confidence interval = 1.06-5.91, P = .04) and any of the infectious complications (odds ratio = 2.23, 95% confidence interval = 1.08-4.59, P = .03) when compared with those who did not have periapical abscess. CONCLUSIONS: Those with periapical abscess are associated with higher odds for infectious complications when compared with those without periapical abscess.

Outcomes of invasive mechanical ventilation in children and adolescents hospitalized due to status asthmaticus in United States: a population based study.

OBJECTIVE: Current national estimates of and outcomes of Invasive Mechanical Ventilation (MV) in status asthmaticus (SA) are unclear. The objective of this study is to estimate the incidence and outcomes of MV in hospitalized SA children and adolescents. METHODS: We used the Nationwide Inpatient Sample (NIS, 2009-2010), the largest all-payer hospital discharge database in United States. All hospitalizations (age ≤21 years) with a primary diagnosis of SA were selected. MV was identified using ICD-9-CM procedure codes. Multivariable regression analyses were used to examine the association between MV and outcomes (Length of Stay (LOS) and Hospital Charges (HC)). RESULTS: Over the study period, of the 250 718 SA hospitalizations, MV was needed for <96 h in 0.37% hospitalizations and 0.18% had MV for ≥96 h. Complications occurred in 12.4% (30 991) of all hospitalizations with pneumonia (10.8%) being the most common. A total of 65 patients died in hospitals (the overall in-hospital mortality [IHM] rate was 0.03%). About 55 of these deaths occurred among those who had MV (4% IHM rate for those receiving MV). The mean LOS and hospital HC included without MV (2.1 d, $11 921) MV < 96 h (4.8 d, $52 201); MV > 96 h (15.6 d, $200 336). After adjustment for patient/hospital level factors, the need for MV was associated with significantly higher LOS and HC (p < 0.0001). Those who had MV<96 h (OR = 2.58, 95% CI = 1.77-3.77) or MV ≥ 96 h (OR = 6.23, 95% CI = 3.87-10.03) had higher risk of developing pneumonia. CONCLUSIONS: Although MV is infrequently needed in children and adolescents hospitalized for SA (0.55% incidence rate), it is associated with higher IHM rate and significant hospital resource utilization.

Lack of dental insurance is correlated with edentulism.

PURPOSE: The correlation between insurance status and edentulism has not previously been reported in a population with known access to a dentist, and little is known about patient demographics in corporate dental settings. This study investigated patient demographics of a former dental franchise in Chicopee, Massachusetts, and examined a correlation between dental insurance and edentulism in this group. The correlation of edentulism with age, gender, and dental risk factors (diabetes, temporomandibular disorder, trouble with previous dental work, or oral sores and ulcers) was also examined. MATERIALS AND METHODS: This was a retrospective case study. Age, gender, and presence of dental risk factors were recorded from the patient medical history intake form. Dentate status was recorded from patient odontograms. Dental insurance status was obtained from billing records. Data was aggregated and deidentified. Descriptive and bivariate statistics and logistic regression models were used to identify associations (p-value ≤ 0.05 significance). RESULTS: Of 1,123 records meeting inclusion criteria, 52.54 percent of patients had dental insurance, 26.27 percent had at least one dental risk factor, and 18.17 percent were edentulous. Age and insurance status were significantly correlated with edentulism. Correcting for age, individuals without insurance were 1.56 times as likely to be edentulous. CONCLUSION: This case study provides insight into patient demographics that might seek care in a corporate setting and suggests that access to a dentist alone may not be adequate in preserving the adult dentition; dental insurance may also be important to health. As the corporate dental practice model continues to grow, these topics deserve further study.

Presence of gingivitis and periodontitis significantly increases hospital charges in patients undergoing heart valve surgery.

OBJECTIVE: To examine the prevalence and impact of gingivitis and periodontitis in patients having heart valve surgical procedures. METHODS: Nationwide Inpatient Sample for the years 2004-2010 was used. All patients who had heart valve surgical procedures were selected. Prevalence of gingivitis/periodontitis was examined in these patients. Impact of gingivitis/periodontitis on hospital charges, length of stay, and infectious complications was examined. RESULTS: 596,190 patients had heart valve surgical procedures. Gingivitis/periodontitis was present in 0.2 percent. Outcomes included: median hospital charges ($175,418 with gingivitis/ periodontitis versus $149,353 without gingivitis/periodontitis) and median length of stay (14 days with gingivitis/periodontitis versus 8 days without gingivitis/periodontitis). After adjusting for the effects of patient- and hospital-level confounding factors, hospital charges and length of stay were significantly higher (p < 0.001) in those with gingivitis/periodontitis compared to their counterparts. Further, patients with gingivitis/periodontitis had significantly higher odds for having bacterial infections (OR = 3.41, 95% CI = 2.33-4.98, p < 0.0001) when compared to those without gingivitis/periodontitis. CONCLUSION: Presence of gingivitis and periodontitis is associated with higher risk for bacterial infections and significant hospital resource utilization.

Outcomes of Oral Health Screenings at Two Different Institutions Serving Individuals with Special Health Care Needs in Massachusetts.

BACKGROUND: As part of the 2009-2010 Massachusetts Dental Society Leadership Institute, two oral health screening and prevention education programs were conducted at institutions in Massachusetts that serve individuals with special health care needs (ISHCN). METHODS: Members of the Leadership Institute class of 2009-2010 built relationships with two institutions that served individuals with ISHCN-one that housed residents with special health care needs and another that served as a day-care facility. Oral health screenings were conducted at both institutions. Retrospective analysis of the data from the two screenings is presented in the current study. RESULTS: Forty-four oral health screenings were conducted at the organization that acted as a daycare/drop-in center for ISHCN who reside in a family home, and 21 screenings were conducted of ISHCN at a residential facility. Among those residing in family homes, 23 percent needed urgent care whereas only 5 percent who were living in an institution needed urgent care. Overall, a total of 40 percent had untreated caries and 48 percent were free of caries based on the oral health screenings. Sixteen percent of subjects were in pain from their mouth at the time of the screenings.

Poor Oral Health Linked with Increased Risk of Infectious Complications in Adults with Leukemia.

OBJECTIVE: The objective of this study is to examine the impact of the presence of gingivitis/periodontitis on the occurrence of infectious complications (including septicemia, bacterial infections, and mycoses) in hospitalized leukemic adults in the United States. METHODS: A retrospective analysis of the Nationwide Inpatient Sample (NIS) for the years 2004-2010 was performed. All hospitalized leukemic patients aged 18 to 65 years were selected. The association between occurrence of gingivitis/periodontitis and infectious complications was examined by multivariable logistic regression models. A total of 135,692 hospitalizations were due to leukemias during the study period. Among these, gingivitis/periodontitis was present in 0.6%. Septicemia occurred in 27.8% of those who had gingivitis/periodontitis (compared to 19.6% in those without gingivitis/periodontitis), bacterial infections occurred in 19.5% of those who had gingivitis/periodontitis (compared to 10.1% in those without gingivitis/periodontitis), and mycoses occurred in 20.7% of those who had gingivitis/periodontitis (compared to 10.7% in those without gingivitis/periodontitis). Patients who had gingivitis/periodontitis were associated with significantly higher odds for septicemia (OR = 1.58, 95% CI = 1.14-2.19, p = 0.01), bacterial infections (OR = 2.15, 95% CI = 1.51-3.07, p<0.01), mycoses (OR = 2.16, 95% CI = 1.43-3.28, p<0.01), or any infectious complication (OR = 2.15, 95% CI = 1.63-2.84, p<0.01) when compared to their counterparts following adjustment for multiple patient and hospital-level confounding factors. CONCLUSIONS: Poor oral health (as defined by the presence of gingivitis/periodontitis) is an independent predictor of increased risk of infectious complications in hospitalized leukemic adults in the United States.

Global Dental Research Productivity and Its Association With Human Development, Gross National Income, and Political Stability.

OBJECTIVE: The objective of this study is to examine the associations between country level factors (such as human development, economic productivity, and political stability) and their dental research productivity. METHODS: This study is a cross-sectional analysis of bibliometric data from Scopus search engine. Human Development Index (HDI), Gross National Income per capita (GNI), and Failed State Index measures were the independent variables. Outcomes were "Total number of publications (articles or articles in press) in the field of dentistry" and "Total number of publications in the field of dentistry per million population." Non-parametric tests were used to examine the association between the independent and outcome variables. RESULTS: During the year 2013, a total of 11,952 dental research articles were published across the world. The top 5 publishing countries were United States, Brazil, India, Japan, and United Kingdom. "Very High" HDI countries had significantly higher number of total dental research articles and dental research articles per million population when compared to the "High HDI," "Medium HDI," and "Low HDI" countries (p < 0.0001). There was a significant linear relationship between the GNI quartile income levels and outcome metrics (p ≤ 0.007). Countries which were highly politically stable were associated with significantly higher dental research productivity (p < 0.0001). CONCLUSIONS: There appears to be a regional concentration of articles with just five countries contributing to over 50% of all articles. The human development and economic development of a country are linearly correlated with dental research productivity. Dental research productivity also increases with increasing political stability of a country.

Emergency department visits with facial fractures among children and adolescents: an analysis of profile and predictors of causes of injuries.

PURPOSE: The objectives of this study were to provide nationally representative estimates of hospital-based emergency department (ED) visits for facial fractures in children and adolescents, examine the burden associated with such visits, identify common types of facial fracture, and examine the role of patient-related demographic factors on the causes of facial fractures. MATERIALS AND METHODS: The Nationwide Emergency Department Sample for 2008 to 2010 was used. All ED visits with a diagnosis of facial fractures in those no older than 21 years were selected. Demographic characteristics, types of facial fracture, causes of injuries, and hospital charges were examined. RESULTS: During the study period, 336,124 ED visits were for facial fractures in those no older than 21 years. Late adolescents (18 to 21 yr old) and middle adolescents (15 to 17 yr old) comprised 45.6% and 26.6% of all ED visits, respectively. Male patients comprised 74.7% of ED visits. The most common facial fractures were those of the nasal bones and mandible. Younger children were more likely to have falls, pedal cycle accidents, pedestrian accidents, and transport accidents, whereas older groups were more likely to have firearm injuries, motor vehicle traffic accidents, and assaults (P < .05). Female patients were more likely to have falls, motor vehicle traffic accidents, and transport accidents, whereas male patients were more likely to have firearm injuries, pedal cycle accidents, and assaults (P < .05). Those residing at low annual income household levels were at a high risk for having firearm injuries, motor vehicle traffic accidents, and transport accidents (P < .05). CONCLUSIONS: Late adolescents, middle adolescents, and male patients comprise a significant proportion of these ED visits. Age, gender, and household income levels are significantly associated with the causes of facial fracture injuries.

Epidemiology of hospital-based emergency department visits due to sports injuries.

BACKGROUND: Sports-related injuries in adolescents incur a significant amount of hospital resources. Sports-related injuries are not an uncommon cause of ED visit; however, national estimates of such injuries in teenagers are unknown. OBJECTIVES: The aim of this study was to identify and characterize emergency department (ED) visits that result from sports-related injuries among teenagers across the United States. This study describes the outcomes associated with sports-related injuries necessitating ED visits among teenagers at a national level. STUDY DESIGN: This is a descriptive epidemiology study. METHODS: The 2008 Nationwide Emergency Department Sample data set, the largest all-payer health care database in the United States, was used to identify ED visits with external cause of injury related to sports occurring in patients aged 13 through 19 years. Outcomes examined included discharge status after the ED visit and presence of concomitant injuries. Descriptive statistics was used to summarize the estimates. Nationwide representative estimates were computed using the discharge weight variable. RESULTS: There were 432,609 ED visits by those between the ages of 13 and 19 years who experienced sports-related injuries, with total charges close to $447.4 million, with a mean total per-visit charge of $1205. The male patients accounted for 76.8% of the total ED visits. The most frequently occurring injuries were superficial injury or contusion (n = 118,250 ED visits); sprains and strains (n = 105,476); fracture of the upper limb (n = 63,151); open wounds of the head, the neck, and the trunk (n = 46,176); as well as intracranial injury (n = 30,726). Close to 29% of all ED visits occurred among those residing in geographical areas with median household income levels of greater than $64,000. After the ED visit, 1.6% were admitted to the same hospital, with a mean length of stay of 2.4 days and a mean hospital charge for ED visit and inpatient services of $22,703. The male patients composed 87.5% of the hospitalizations. The total of hospitalization charges across the entire United States was $154.8 million. CONCLUSIONS: Sports injuries account for a substantial number of 2008 teenage ED visits in the United States. Patient- and hospital-level characteristics were analyzed and highlighted.

Children in the United States make close to 200,000 emergency department visits due to poisoning each year.

OBJECTIVE: The aim of this study was to provide nationally representative hospital-based emergency department (ED) estimate visits in children (aged ≤ 18 y) attributed to poisoning in the United States in 2008. METHODS: Nationwide Emergency Department Sample for the year 2008 was used. All ED visits among children (aged ≤ 18 y) with an external cause of injury for "poisoning" were selected for analysis. Demographic characteristics of the ED visits and outcomes examined included ED charges (EDCs), hospitalization charges (HCs), length of stay in hospital, and disposition after ED visit. RESULTS: During the year 2008, a total of 191,197 ED visits were attributed to poisoning with close to 56% of all ED visits occurring among those aged younger than 4 years. Boys comprised approximately 54% of all ED visits. After an ED visit, 87% were routinely discharged, and 7.3% were admitted into the same hospital. Forty-eight children died in the ED. The frequently reported poisonings included accidental poisoning by other drugs (44,219 ED visits); accidental poisoning by other gases and vapors (27,035 ED visits); and accidental poisoning by analgesics, antipyretics, and antirheumatics (22,334 ED visits). The mean EDC per visit was $1077. The total EDC across the entire United States was $171.8 million. Mean length of stay was 1.9 days. Among those who were hospitalized, the mean HC was $11,792. The total HC across the entire United States was $162.3 million. CONCLUSIONS: The current study provides nationally representative estimates of ED visits attributed to poisoning among children in the United States. High-risk groups and economics associated with treating these injuries are estimated.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

INTRODUCTION: The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. METHODS: The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. RESULTS: A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. CONCLUSIONS: Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics.

An overview of characteristics of registered studies on dental implants.

OBJECTIVE: Clinical trials serve as the empirical basis for clinical decision making. The objective of the current study is to provide an overview of clinical trials examining dental implant outcomes. METHOD: All registered studies on Dental Implants were selected for analysis. The clinicaltrials.gov website was used to query the characteristics of registered studies. The search term used was dental implants. RESULTS: As of the study conduct date (01/01/2014), a total of 205 studies on dental implants were registered. These included 168 interventional and 37 observational studies. Results were available for only 14 studies. All observational studies and 98.8% of interventional studies included both male and female subjects. Close to 60% of studies had sample sizes between 1 and 50. NIH was listed as funding source in only 5 interventional studies and 3 observational studies. 80% of interventional studies were randomized. However, double masking was reported in only 15% of interventional studies with majority being open labeled. CONCLUSION: ClinicalTrials.gov registry was created with the intention of increasing the transparency of conducted or ongoing clinical studies and to minimize publication bias commonly seen with industry-sponsored studies. Results of the current study showed that a predominating number of registered studies are funded by industry and other sources, very few registered studies have made their results public, and the ClinicalTrials.gov registry does not provide sufficient information on the quality of study design and thus precluding the public and researchers to judge on the quality of registered studies and publication bias.

Variation in response to the coronavirus disease 2019 (COVID-19) at US dental school clinics.

PURPOSE: Although the threat of coronavirus disease 2019 (COVID-19) was the same at different US dental schools, the response wasn't. There is no study that documents the variation in mitigation strategies, COVID-19 transmission, and clinical educational changes at US Dental schools during the ongoing pandemic that began in 2020 in the US. METHODS: The current study was approved as exempt research (project number HUM00199261). Our survey of Associate Dean's of Clinical Operations was individually emailed in July 2021. There were no reminders and descriptive statistics were calculated using Microsoft Excel. RESULTS: We received 46 completed surveys from the 68 sent out. Note that 65.2% of respondents reported requiring N95 masks for aerosol-generating procedures. Note that 38.9% of respondents said they required student partnering as chairside dental assistants for aerosol-generating procedures. Note that 37.7% of respondents began using alternate cubicles. A total of 6.52% of schools reported a transmission of the severe acute respiratory syndrome coronavirus 2 virus from patient to provider. There were no reported transmissions from provider to patient or from patient to patient. CONCLUSION: In our study, we found a lot of similarities between the approach taken by Dental School Clinics across the US to mitigate the risks of COVID-19, however, we also observed many differences.